Two products with technologies for safer treatment of chronic pain – oral and transdermal
The problem with misuse and abuse of opioids has increased over the last decades and is a major issue in the United States and a growing problem globally. By overriding the control release mechanism, the opioid gets available for abuse and also subjects the users for high risk of severe side effects and lethal overdose. The FDA therefore requests more products with abuse deterrent formulations. One of these frequently abused opioid products is controlled release tablets containing oxycodone. Emplicure AB has developed a geopolymer matrix with high mechanical strength and good resistance against extraction in different solvents for controlled release of potent active substances. The opioid oxycodone is during the manufacturing process incorporated in pellets of the ceramic material and the product can deliver a controlled release of the active substance for 6 to 24 hours. The next step in the development is to perform a preclinical and then clinical studies.
Current patches for transdermal delivery of fentanyl around-the-clock are related to increasing numbers of misuse and abuse primarily by oral ingestion, inhalation by smoking and injection after dissolution of the patch. Emplicure AB has developed a patch with an abuse deterrent formulation based on a geoplymer formulation where the active substance is incorporated in a geopolymer matrix with high mechanical strength and resistance against extraction in different solvents. The next step for this product is to enter clinical phase.
Inhalation for early onset of effect of active substances
Many diseases and symptoms, especially pain often requires fast relief. Emplicure has developed an inhalation technology based on ceramic materials where the active pharmaceutical substance is incorporated into the material and a ceramic dose unit is formed. Nicotine can also be used, e.g. in products for smoking cessation. The active substance or the nicotine evaporates upon heating in an electronic device and the drug becomes available for inhalation and fast administration via the lungs. The device can be connected to a smart phone and e.g. statistics of use and use control can be applied. This product is in formulation development phase.
Micro-needle patch for drug delivery
This technology provides an alternative for drug delivery when the patient, often children, are afraid of syringes and needles. Emplicure has developed a microneedle technology using self-setting bioceramics and the active substance is incorporated in the ceramic material which is molded into microneedles. Since the needles are in the micro-scale the application is painless. This is a product for local and/or systemic administration of potent active substances with improved performance compared to current products, such as painless and easy drug administration and short time until effect. The next step in the development will, after further optimization of the formulation, be to perform a preclinical study.